MINISTRY OF EDUCATION AND TRAINING HO CHI MINH CITY UNIVERSITY OF TECHNOLOGY AND EDUCATION FACULTY FOR HIGH QUALITY TRAINING INDUSTRIAL MANAGEMENT ASSESSMENT OF APPLICATION SUPPLIER
Reasons of subject selection
Organizations often opt to utilize services or products from suppliers due to a lack of resources, insufficient expertise, or the need to concentrate on their core competencies This trend is particularly prevalent in manufacturing, where increasing specialization plays a significant role Suppliers typically offer superior price and quality, making their services essential for businesses aiming to remain competitive.
A supplier quality management system aims to instill confidence in a supplier's capability to consistently provide products and services that meet established standards and requirements Additionally, it enhances the management of supplier relationships, fostering mutual growth and benefits.
In recent years, health and medicine have increasingly become integral to our daily lives, especially in light of global health challenges such as natural disasters and the significant impact of the Covid-19 pandemic on the economy and healthcare Medical devices have emerged as crucial tools for ensuring effective medical examinations and treatments, directly influencing people's health and well-being To ensure that medical devices meet specific requirements and standards, enterprises must implement a robust quality management system to maintain control and ensure compliance.
Terumo BCT Vietnam prioritizes quality management in medical device manufacturing with a commitment to "Do It Right In The First Time." Any defects identified during inlet inspections are rejected, and suppliers are engaged if their products are deemed to impact overall quality This highlights the critical role of supplier quality management at Terumo BCT Vietnam Consequently, the focus of this thesis is on the "Assessment Of Application Supplier Quality Management Procedure At Terumo BCT Vietnam Co., Ltd."
Research objectives
- To comprehend supplier quality management procedures at TBV
- To analyse the SQM procedure and evaluate good points, limitations of its base on reality implementation
As an SQM intern with hands-on experience, I recommend several strategies to enhance the effectiveness of the implementation procedure By focusing on clear communication, regular feedback loops, and thorough training, organizations can streamline processes and improve overall outcomes Additionally, leveraging technology for better data management and analysis can significantly boost efficiency and decision-making Implementing these suggestions will lead to a more effective and cohesive implementation process.
Research Methodology
Analysing method summarizing experience, interviewing experts and collecting related documents
Research Subject and Scope
- Subject: Supplier Quality management procedure of Terumo BCT Vietnam Company
- Scope: The study focuses on the SQM department of Terumo Blood Cell Technologies Vietnam Co., Ltd from September 7 th , 2020 - January 6 th , 2021
Thesis structure
The content of the thesis is divided into 4 chapters:
Chapter 1: Introduction About Terumo BCT Vietnam
Chapter 3: Analysis of Application Suppliers Quality Management Procedure At Terumo BCT Vietnam Co., Ltd
Chapter 4: The Solutions Improve the Supplier Quality Management System At Terumo BCT Vietnam Co., Ltd
INTRODUCTION ABOUT TERUMOBCT VIETNAM
General About Terumo BCT Vietnam
1.1.1 Established history and development of Terumo
Figure 1.1: Terumo Corporation (Source: Terumo Report 2020)
Terumo Corporation was founded in 1921 by several scientists and doctors, including
Dr Shibasaburo Kitasato, to produce clinical thermometers in Japan These vital medical devices had previously been imported until they were cut off because of World War I
Dr Kitasato's enduring legacy is encapsulated in his belief that scientists must avoid complacency in their advanced research; instead, they should focus on ensuring that their findings are applied for the betterment of society.
Terumo's unwavering corporate mission, "Contributing to Society through Healthcare," reflects its commitment to innovation in medicine Inspired by Dr Kitasato's legacy, Terumo aims to deliver exceptional advancements that enhance patient care.
Figure 1.2: Group Logo (Source:Terumo.com)
The Terumo Group Logo embodies the dedication of every Terumo Associate to gain the trust of medical environments and embrace challenges to generate new value, aligned with our mission of "Contributing to Society through Healthcare." The green lettering of "TERUMO" signifies trust, while the red line reflects our spirit of challenge.
Parent company: Terumo Corporation, established in 1921, Tokyo Stock Exchange
Global Headquarter: Lakewood, Colorado, USA
Terumo BCT Vietnam (TBV) has been a key player in the hematology industry since its establishment in 1994, significantly impacting the health sector The company’s blood bags, transfusion lines, and equipment are widely used in hospitals across Vietnam, contributing to the growth and development of the blood transfusion industry in the country.
Established in 2014, TBV in Long Thanh spans 91,440 square meters with an investment exceeding 100 million USD, targeting markets in Southeast Asia, Europe, and America By July 2020, TBV employed over 1,800 associates, with more than 85% working in the production area, while the remainder supports functions like quality assurance, engineering, and information technology.
5 services The factory is still in a stable phase and with challenging goals to expand production capacity, the company estimates it will double its workforce by the end of
As a medical equipment manufacturer, quality is always a top concern at TBV From
2014 to now, TBV has obtained the following quality certificates:
✓ ISO 9001: 2015: Design and manufacture of medical equipment related to blood storage
✓ ISO 13485: 2016: Manufacture and assembly of blood-related medical devices and blood components
✓ ISO 11607: Sterilization of medical devices, periodic packaging of sterilized products
✓ ISO 14971: 2012, ISO 13485: 2016: Risk management applications
✓ FDA: Food and Drug Administration
❖ Mission: “Contributing to Society through Healthcare”
Terumo contributes to society by providing valued products and services in the healthcare market and by responding to the needs of patients and healthcare professionals
❖ Vision: “Innovating at the Speed of Life”
As society changes constantly and science and technology advance, Terumo remains focused on lives, and on rapidly bringing new value to medical settings
Terumo upholds a commitment to open management, aiming to provide appropriate returns to our stakeholders while focusing on global business development as a leader in the industry.
Terumo emphasizes the importance of scientific thinking, creativity, and time appropriation, and respond in depth to customer needs by creating valued products and services
Terumo pride ourselves on our commitment to the development of technologies and quality assurance systems that ensure safe, reliable products
Terumo is committed to respecting individuals, fostering intercultural understanding, and promoting openness in the workplace, aligning with our slogan, “Associate Spirit,” as we prepare to tackle future challenges.
Terumo conducts our business activities in a fair and equitable manner and act responsibly toward the environment as Terumo fulfill our responsibilities as a good corporate citizen
1.1.4 Quality policy and Quality objective FY 2020
Continuous Improvement Creates Quality that Delights Customers
Terumo BCT is dedicated to the ongoing enhancement of our systems, services, products, and processes, as well as the skills of our associates and the efficiency of our Quality Management System We set high standards and Quality Objectives to ensure compliance with regulatory and stakeholder requirements.
In-process Quality: First pass Yield >= 80%
1) No external warning letter or equivalent
3) 99% on-time regulatory required training
Terumo demonstrates respect and appreciation for its associates, customers, and business partners by valuing individuality and diverse cultures The company actively listens to a wide range of opinions and the voice of society, fostering an inclusive environment.
❖ Integrity – Guided by our mission
As associates of Terumo Group, responsible for life and health, Terumo always acts with sincerity and a sense of mission Through our daily efforts, Terumo builds trust among all stakeholders
Terumo is mindful that everything Terumo does ultimately connects us to patients Terumo strive to understand health providers deeply and work together with them to give patients a better future
To ensure safety and reliability in healthcare, Terumo views each issue from a
“Gemba” perspective to find the optimal solution As well as product quality, Terumo pursues excellence in all Terumo do, from product supply to customer care
Terumo fosters a forward-thinking mindset driven by curiosity and passion, addressing the needs of "Gemba" by providing timely products and services that deliver significant value.
Business Activities At TBV
The Blood and Cell Industry promotes customer value and enhances patient outcomes through therapies related to blood composition, blood separation, and cell technology
The Blood Management Company drives customer value and enhances patient outcomes through blood component, therapeutic apheresis, and cellular technologies
The Blood and Cell Technologies Company offers a diverse array of products, including instruments for blood centers that separate and produce blood components for transfusions, as well as tools for cell therapy and therapeutic apheresis Additionally, it provides biotech and cell processing equipment for research institutions As a key subsidiary of Terumo, specifically Terumo BCT in the United States, the company enhances the quality of life for patients in over 130 countries, supporting medical facilities in the blood and cell sectors.
With a spirit of collaboration with medical settings and compassion for patients, Terumo BCT pursues unique technologies to bring about better-quality transfusions, blood treatments, and cell therapies
Technologies that Contribute to Transfusions and Cell Therapy:
❖ Large blood loss in accidents or surgeries
Technologies that enable safe and efficient production of blood components to bring donor blood to more patients
❖ Treatment of blood diseases, therapeutic apheresis
Cell collection needed for treatment of leukemia, removal of disease-causing substances from blood
❖ Cell therapy to treat cancer and other difficult diseases
Technology to wash, separate, concentrate, and cultivate cells collected from the blood of donors or the patient, to utilize cellular functions in cell therapy
Figure 1.3: Trima Reveos (Source:Terumo.com)
❖ Blood Bags and Blood Bags with Inline Filters
Blood bags will be used to store blood when you donate blood in hospital donation programs
Figure 1.4: Blood Bag (Source:Terumo.com)
Blood bags, essential for collecting, storing, transfusing, and transporting blood, are utilized in blood transfusion centers and hospitals These bags feature a soft texture and come in various types, including those with CPD anticoagulant solutions, CPDA-1, and SAGM red blood cell preservative solution, AS-5.
Our blood collection bags come in various sizes, including single, double, triple, and quadruple options, with volumes of 250ml, 350ml, and 450ml, making them ideal for whole blood collection and blood product production Each blood collection and production line is automatically checked to ensure compliance with international medical hygiene and quality standards Additionally, safety and shelf-life parameters are clearly labeled on each bag, accompanied by a small box for convenient usage.
A blood separator is utilized to separate blood into its four primary components: red blood cells, white blood cells, platelets, and plasma Typically, a patient requires only one of these essential components for treatment.
The Trima Accel (Trima) is an advanced blood collection and transfusion device that utilizes centrifugation to efficiently separate blood components, including platelets, plasma, and red blood cells This device quickly sorts these components based on their density and size, allowing for the precise collection of desired ingredients while safely returning the remaining components to the donor.
Figure 1.5: Trima Disposable Sets (Source:Terumo.com)
The Trima Accel system efficiently collects blood components by adhering to two key criteria: it prioritizes collection based on configured needs and ensures donor safety by considering physiological factors and cell counts This advanced blood component collection device operates within a comprehensive system that includes the Trima Accel device, a series of tubing sets, and integrated software Additionally, the system is designed to manage two modes of hemolysis.
Indirect blood separation involves the donation of blood at a blood bank, where it is processed for component separation The whole blood is passed through a Trima Accel automatic blood cell separator, followed by the Trima Kit blood separator, which divides the blood into its individual components stored in separate blood sacs.
Direct blood separation effectively addresses the treatment needs of thrombocytopenic patients This method is advantageous for both patients and blood donors, as it involves collecting only platelets and a minimal amount of plasma to dilute red blood cells, which are then returned to the donor Consequently, this process has a negligible impact on the health of blood donors.
Terumo BCT's customers are mainly medical organizations, health organizations, hospitals in more than 160 countries around the world such as Japan, Belgium, UK, America, South Africa, Brazil,
One of the most typical customers of Terumo BCT Vietnam is Japan Red Cross In Vietnam, TBV blood bags are only available at the National Hospital of Hematology (Hanoi)
❖ The company's distribution channel system
Terumo BCT Vietnam operates under the global sales coordination department of the Terumo Group and does not directly distribute products to customers Instead, branches and representative offices in over 150 countries handle customer interactions in their respective regions Upon receiving customer orders, these branches forward their requests to Terumo BCT Vietnam, which then manufactures or ships the products to the designated address of Terumo BCT INC (Headquarters).
Figure 1.6: Blood bag manufacturing process (Source: Blood bag manufacturing process in Terumo BCT)
Figure 1.7: Trima manufacturing process (Source: Trima manufacturing process in
Company Organizational Size
Figure 1.8: TBV Organizational structure (Source: TBV Introduction)
The General Director serves as the top authority within the company, bearing legal responsibility for all operations and asset management Additionally, this role involves the direct oversight and management of the company's activities.
Control the quality of goods and materials and ensure compliance with quality processes such as ISO, FDA
- Quality Control (QC): quality control of input materials, semi-finished products and finished products
- Quality Assurance Department (QA): ensures all operating departments comply with quality management procedures Prevent non-compliance actions and propose corrective and preventive action Make reports to customers when necessary
- Quality Engineer Department (QE): research on material quality, product quality, then offers solutions to improve product quality
A Quality Management System (QMS) is essential for reviewing and issuing the latest documentation that defines product configuration and regulatory control in the production process It is crucial to implement TBV processes in compliance with ISO standards Additionally, ensure that all documents in use are valid, with soft copies stored in shared memory and hard copies properly recorded and stored.
The technical department is responsible for monitoring and maintaining the company's systems, addressing any issues or necessary changes, and implementing new processes They ensure optimal performance of equipment and machinery through continuous communication with engineers.
❖ Supply Chain Management Department (SCM):
The head of a department manages a series of work that are closely related to each other
- Planning Department: works directly with the global planning department, receiving information and orders from all over the world from which to plan production, shipment and storage
- Purchasing: plans to purchase materials for production Buy consumable items, machinery and equipment, and find service providers that meet the needs of all parts of the company
- Import and Export (Logistics): works with import and export service providers to complete import and export tasks
- Warehouse department: arranges, stores goods and prepares goods for export to customers
The production department is divided into two main production lines based on two product lines, the Blood Bag and the blood ingredient collection device (Trima Accel)
- Production Control (PC): perform jobs such as issuing production orders, monitoring, collecting production data
- Process Maintenance (PM): repair and plan maintenance of machines, calibration of equipment, tools
Establish, manage and implement projects to develop, evaluate new products, machines and lines
❖ Environment Health Safety Department (EHS):
They inspect and assess the environment, equipment, and processes in workplaces to ensure adherence to safety regulations, with the primary goal of safeguarding employees in their working environment.
The role involves overseeing general office management, including the maintenance of equipment such as copiers, printers, and phones, as well as managing utilities like electricity and water It requires effective communication with internal staff regarding administrative support and monitoring timesheets for employee attendance, including absences and vacations Additionally, responsibilities include managing stationery inventory, coordinating travel arrangements, and maintaining up-to-date employee medical records.
They solve problems about software, hardware and system troubles and provide computing facilities of other departments Their responsibility is to protect confidential information of TBV
Finance department duties include financial planning, reporting and controls, short and long-term business strategy, investments, hedging, cash management, internal risk management, corporate finance, auditing, and accounting
HR plays a crucial role in recruiting skilled employees, ensuring an effective workforce that contributes to the company's success They manage salary issues, company policies, staff planning, and benefits such as social and labor insurance Additionally, HR is responsible for establishing training and development plans for employees, evaluating training outcomes, and making necessary adjustments to align with real-world needs.
1.3.2 Introduction Supplier Quality Management Function (SQM)
The SQM Function, integral to the Quality department, is tasked with ensuring the quality of products and services from suppliers This includes conducting incoming inspections, monitoring supplier performance, implementing corrective actions, facilitating supplier improvements, and evaluating and approving suppliers The SQM team is organized into three smaller teams to effectively manage these responsibilities.
The role involves overseeing material testing at TBV to meet company objectives Key responsibilities include inspecting received materials, such as API, components, and consumables, to ensure they meet specified standards Additionally, the position requires managing all records associated with testing processes.
19 including inspection records Sampling samples Monitor equipment calibration and maintenance And identify the problem (NC) and potential problem that can affect to quality
SQA oversees approved supplier quality management at TBV, addressing supplier quality issues, controlling blocked materials, and conducting supplier audits and performance monitoring Suppliers are classified according to the levels defined in the supplier qualification SOP, with re-qualifications carried out annually or as required by management, along with recommendations for business continuity SQA is responsible for verifying and monitoring the on-hold material warehouse and establishing performance metrics for suppliers at levels 1-4 Ongoing supplier performance data is reviewed to adjust supplier status accordingly A comprehensive supplier file is maintained for each supplier, contractor, or consultant, and an audit plan is established to ensure compliance with quality specifications Additionally, SQA initiates and monitors nonconformance issues, implements corrective actions, and verifies their effectiveness Regular reports are prepared, quality meetings are attended, and quality data trends are documented, all while managing records in accordance with QMS requirements.
Supplier Engineering focuses on enhancing the reliability and repeatability of supplier processes while addressing quality issues effectively Supplier Engineers are required to have expertise in process controls, project management, process validation and verification, process improvement, supplier management, and CAPA investigations.
Functions as a member of the Supplier Engineering Team working cross-functionally and proactively on supplier quality and management activities These activities include:
To ensure effective supplier selection, it is essential to conduct thorough qualifications for new suppliers and any proposed changes This includes coordinating and performing supplier audits to evaluate potential partners Additionally, establishing and maintaining material specifications, along with validating incoming inspection methods, is crucial Providing technical support and guidance to the quality team helps address quality issues effectively Collaboration with quality inspectors throughout the project lifecycle ensures a comprehensive understanding of all items, components, and assembly technical details Finally, developing a strategic plan to enhance supplier capabilities is vital for long-term success.
Engineering and Purchasing collaborate to enhance supplier development by strategically leading performance improvement initiatives These projects aim to boost supplier capabilities in consistently meeting TBV requirements and may involve process analysis, value stream mapping, process capability assessments, throughput analysis, as well as methodologies like 6-Sigma, 5S, and Kaizen events.
THEORETICAL BASIS
Quality
There are many definitions of quality available in the literature states the following:
Quality can be defined in various ways, with Philip B Crosby stating that it is conformance to requirements Juran adds that quality is about fitness for use, while W Edwards Deming emphasizes that good quality involves predictability, uniformity, and reliability at a low cost, making it acceptable to the market.
ISO 9001:2015 emphasizes that a quality-focused organization cultivates a culture that shapes behaviors, attitudes, and practices to deliver value by meeting the needs and expectations of customers and stakeholders The quality of a product or service is assessed based on its usability, customer perceptions, and its impact—both positive and negative—on relevant parties.
Quality encompasses adherence to a wide range of requirements, not just technical specifications for products It includes mutually agreed-upon terms such as delivery conditions, frequency of deliveries, packaging standards, storage conditions, pricing, and punctuality in delivery.
Supplier Quality Management
According to ISO 9000:2015, a supplier is defined as an organization that provides products, which can include hardware, software, or processed materials This means that suppliers can be manufacturers, distributors, retailers, contractors, or subcontractors Organizations often choose to source products or services from suppliers due to a lack of resources, expertise, or to concentrate on their core strengths, a practice that is particularly prevalent in the manufacturing sector amid growing specialization.
Supplier quality refers to a supplier's capability to deliver goods or services that meet customer requirements Effective supplier quality management involves a proactive and collaborative system to oversee and enhance the quality provided by suppliers.
This is usually done by a supplier's quality management system (QMS), which allows companies to monitor their supply chain and periodically inspect or review raw materials and service
Supplier quality management is initiated during the product design and supplier selection phases and persists throughout the product's lifecycle and the ongoing relationship with the supplier.
ISO 13485 mandates rigorous supplier control to ensure products meet defined requirements and specifications To achieve this, companies must implement a quality system that effectively manages and monitors supplier performance Consequently, section 7.4 of the Standard integrates supplier control into the overall quality management system.
Supplier Quality Management Activities
Enterprises must ensure that third-party products and services comply with ISO 9001:2015 standards Section 8.4 outlines the necessary instructions for controlling externally provided products and services.
Supplier selection is a critical process that emphasizes honesty, transparency, and fairness It involves evaluating suppliers to ensure they can deliver products or services that meet specific requirements prior to making any purchases Consequently, the criteria used for supplier evaluation and selection should enable organizations to make informed decisions about a supplier's competence, minimizing reliance on subjective feelings.
Supplier selection criteria evolve over time, influenced by the political, economic, social, and environmental factors of the business landscape, as noted by Sagar and Singh (2012) They identified 21 key criteria for supplier evaluation, which include price, quality, industry reputation, delivery performance, financial stability, technical capability, and the ability to maintain long-term relationships Additional factors encompass compliance with quality standards, responsiveness, effective communication systems, warranty policies, certifications like ISO 9001 and ISO 14000, and overall performance history.
Figure 2.1: Supplier Quality: Selection and Development Flowchart Example
(Source: What Is Supplier Quality? - ASQ) According to ASQ, common vendor and supplier selection criteria includes:
✓ Previous experience and past performance with the product/service to be purchased
✓ Relative level of sophistication of the quality system, including meeting regulatory requirements or mandated quality system registration (e.g., ISO
✓ Ability to meet current and potential capacity requirements on the desired delivery schedule
✓ Technical support availability and support in developing and optimizing processes
✓ Total cost of dealing with the supplier, including material cost, communications methods, inventory requirements, and incoming verification required
✓ The supplier's track record for business-performance improvement
2.3.2 Developing an approved suppliers list
Manufacturing companies utilize an approved supplier list to evaluate each supplier's performance based on cost, quality, and delivery Categorizing suppliers enhances efficiency and adds value to the procurement process.
SQM procedure ensure that the suppliers provide the right products/ services Standards may include lead times, methods of delivery, quantity, quality, packaging, storage and other requirements
Suppliers categorizations identify which suppliers are important and the criteria to consider This provides better supplier control and management and makes re- evaluation easier and more efficient
The ISO 9001 standard classifies suppliers in three ways:
✓ Supply of raw materials, materials and equipment
Classify suppliers by risk level and accordingly prioritize performance quality assessments
Figure 2.2: Classify suppliers by risk level (Source: complianceonline.com)
Suppliers identified as having the highest supply and quality risks will undergo annual re-evaluation This assessment will consider factors such as corrective actions taken by suppliers, return rates, on-time delivery performance, and customer complaints related to suppliers These suppliers significantly influence the quality and availability of products.
Heavy Risk suppliers represent the second tier of supply and quality risk, necessitating re-evaluation every two years based on their corrective actions and on-time delivery performance While they directly affect the product, alternatives are available to mitigate potential issues.
Moderate Risk suppliers - Suppliers under this classification are "category" with a
Products or services classified as having a "minor" quality risk will be assessed every three years, focusing on timely delivery and pricing, as they indirectly affect the overall product quality.
Low-risk suppliers - The lowest level of supply and or quality risk Suppliers that are in this classification have no significant impact on the final product
❖ Filtering information in approved list to manage suppliers
The categorization and re-assessment process will yield a list of approved suppliers (ASL), indicating which suppliers are accepted, which need improvement, and which are prohibited from ordering This ASL will serve as a quality record and will be managed in accordance with the guidelines outlined in clause 4.2.5 of ISO 13485:2016.
The Suppliers Master List (ASL) is an essential tool for effectively managing suppliers, enabling companies to optimize their resources and maximize value from the supply chain.
And it also the most effective audit planning support that will have the greatest impact on suppliers' performance and the manufacturer
The ISO 9001:2015 standard requires organizations to establish and choose criteria for evaluating, selecting, monitoring, and reassessing suppliers, focusing on their availability and the processes, products, or services that meet specific requirements.
A supplier audit involves the assessment and evaluation of a supplier's operations to identify any non-conformities with regulations, ISO standards, and the agreements made between the supplier and the company.
There are two main types of suppliers evaluation: Off-site audit and on-site audit
1) Questionnaire-type supplier audits (Off-site audit)
Young (2019) said that a questionnaire is effective at collecting basic factual data about an organization, rather than determining how effective and efficient their
The article discusses 28 processes and suggests a questionnaire to address key queries regarding supplier quality standards, personnel numbers, and the types of industries served along with their respective quantities It emphasizes that conducting an on-site supplier audit is often the most effective method for obtaining detailed and trustworthy information.
On-site audits will give SQM team all the information from questionnaire-based reviews and more, such as:
The company's Quality Management System (QMS) is structured to effectively manage products and processes, utilizing performance data to drive improvements Internal audit results from suppliers and certification audits provide insights into operational efficiency This framework fosters a tangible understanding of the company's operations and the overall organizational atmosphere.
Young (2019) suggests that an informal check of the supplier during a facility visit can yield valuable insights By observing the production area, warehouse, and other properties, the SQM team can gather important information about the supplier's operations (intouch-quality.com).
ISO 9001:2015 emphasizes the critical need for re-evaluating external suppliers to ensure they consistently uphold their quality management systems This process guarantees that suppliers remain competent and meet performance requirements, supported by reliable evidence of their ongoing capabilities.
Poka-yoke method
Poka-yoke, a Japanese term meaning "mistake-proofing," refers to techniques designed to prevent inadvertent errors Developed and formalized by Shigeo Shingo in the 1960s as part of the Toyota Production System, Poka-yoke devices are essential for ensuring that defects do not occur Shingo's innovative approach involved creating simple mechanisms that eliminate the possibility of mistakes, as a mistake only becomes a defect when it reaches the customer.
Such defective actions can be component missing (not assembled), wrong component processed / assembled, part wrong processed / assembled and operational and setting defects
Therefore, Poka-Yoke has the goal, through simple but effective technical measures to eliminate defective actions from human beings
Vinod et al (2015) introduced a framework for evaluating Poka-Yoke devices, defining them as tools that prevent abnormalities in processes and safeguard worker health and safety They categorized Poka-Yoke devices into three types: physical, functional, and symbolic Additionally, the RNA Automation website outlines two approaches for implementing Poka-Yoke devices.
Controls - prevents and/or stops the process: This approach senses a problem and stops a line or process so that corrective action can take place immediately, thus avoiding serial defect generation
Warnings and alarms serve to indicate deviations or trends in processes through a series of escalating signals, such as buzzers and lights Unlike control methods, which halt operations upon each deviation, the warning approach allows the process to continue running without immediate shutdown.
Figure 2.3: Types of Poka-yoke (Source: RNAautonomation.com)
Shigeo Shingo identified three types of poka-yokes: the Contact method, the Fixed-Value method, and the Sequence method Each of these methods can be applied using either a Control approach or a Warning approach.
Contact method - identifies defects by testing product characteristics
Fixed-value - a specific number of movements every time
Sequence method - determines if procedure were followed
Defects identified in the later stages of a process incur higher costs due to the involvement of additional materials, labor, and overhead, as well as the risk of previously reworked products If a defective product reaches the customer, the intangible costs, such as damage to reputation, can far outweigh the tangible expenses.
Go/no go testing is a binary classification method that determines pass or fail outcomes based on two boundary conditions The test is considered successful only when the Go condition is satisfied and the No go condition is not met.
The test does not indicate the extent of adherence to or deviation from the boundary conditions However, it can be utilized for statistical process control (SPC) purposes Specific SPC tools, such as P-charts, employ parameter-based measurements to assess process stability.
Figure 2.4: Go/No Go Gages (Source: DMC Daniels Manufacturing Corporation)
Flowchart
A flowchart is one of the seven essential quality control tools used for troubleshooting production process issues within organizations It provides a visual representation of a sequence of steps in an operation, illustrating inputs, activities, decision points, and outputs This diagrammatic tool aids in understanding the overall objectives of a process and serves as a systematic approach to identify and analyze potential problem areas By documenting and explaining operations, flowcharts are invaluable for enhancing quality and improving processes (Forbes and Ahmed, 2011).
In assembly language programming, six fundamental flowchart symbols are frequently utilized: Terminal, Process, Input/Output, Decision, Connector, and Predefined Process While this list highlights the most commonly used symbols, it is not exhaustive, as numerous standard flowcharting symbols exist.
Process Indicates any type of internal operation inside the Processor or Memory
Input/ Output Used for any Input / Output (I/O) operation
Indicates that the computer is to obtain data or output results
Decision Used to ask a question that can be answered in a binary format (Yes/No, True/False)
Connector Allows the flowchart to be drawn without intersecting lines or without a reverse flow
Used to invoke a subroutine or an interrupt program
Terminal Indicates the starting or ending of the program, process, or interrupt program Flowlines Shows direction of flow
ANALYSIS OF APPLICATION SUPPLIERS QUALITY
SOP for Supplier Quality Management (SQM)
This procedure aims to define the requirements for managing suppliers to guarantee that all purchased, subcontracted, or received products and services meet specified standards.
This procedure outlines the classification, evaluation, selection, monitoring, and control of suppliers, contractors, and consultants The required controls are determined by the impact of the product on the quality, safety, and effectiveness of the final device.
Figure 3.1: Supplier management overview (Source: SQM procedure VQS0006_E)
Establishing controls for products and services from suppliers involves six key phases: planning, selecting potential suppliers, evaluating and accepting suppliers, finalizing controls, ensuring delivery, and implementing measurement and monitoring, along with feedback and communication.
Table 3.1: Supplier Quality Management Process Map
No Phases Description SOP Responsi ble
- Define what is to be obtained: specifications, part requirements, procedure, work instructions…
- Identify potential suppliers, risk(s) and controls
Planning for New Supplier(s) Evaluation SQA
Select potential supplier(s) based on investigation about their business and operational capability (logistics, quality, technical risks…)
Evaluate and make final decision
(acceptable or not) for potential supplier(s) that meet specified requirements, including quality requirements
Define the type and extent of control to be exercised over product/services and supplier(s)
Establish checkpoints to monitor the supplier‘s performance and maintain records of acceptable suppliers
Receiving Materials RQA Material Inspection RQA
Communicate between manufacture and suppliers to resolve the problems or develop process, quality of product, services obtained from suppliers
The SQM team established a rigorous procedure to ensure that all purchased, subcontracted, or received products and services meet specified requirements Achieving these objectives will facilitate smoother operations for other departments, particularly production and supply chain, ultimately driving the company's rapid development.
Process is very detailed owing to including all subsequent procedures to instruct employees do their tasks right
3.1.1 SOP for Planning for New Supplier(S) Evaluation
This procedure aims to outline the planning necessary for determining the extent of controls for products and services sourced from both direct and indirect suppliers (levels 1 and 2) Terumo BCT Vietnam anticipates specific outcomes from its suppliers, with success metrics established to evaluate performance Additionally, a timeline for project completion will be defined.
Figure 3.2: Flow chart Planning for New Supplier(S) Evaluation (Source: SQM procedure VQS00100_A) 1
The outcome of this procedure, CFT needs to define as below requirement:
- Identification of what product or service to be obtained from suppliers It may include components, raw materials, metrology, cleaning or sterilization services, authorized representative
Technical and process information encompasses essential product or service specifications, including details on parts, materials, and processes It also involves Quality Management System (QMS) requirements such as work instructions, QMS audits, post-market data, design, calibration, and verification activities.
- Identification of potential supplier(s), it may be internal or external, and their contact information (name, address, payment, etc.)
The CFT must assess the risks associated with products or services, taking into account whether the part is custom-built or off-the-shelf, the impact of the part on manufacturing processes, and the criticality of the part.
+ Information about suppliers should be used to determine additional potential risks (business risks such as financial viability, continuity of supply, capital investment, etc.)
- Identification of risks will be evaluated to determine the type and extent of control(s) These controls will be defined and documented include any quality requirement
The flow chart above shows the steps in detail And the SCM team got the information for the purchasing Materials and Services procedure
3.1.2 SOP Purchasing Materials and Services
As soon as the need for the materials to be purchased is determined, the supplier conducts research and selects the supplier
- For materials that have been used regularly, investigate further to choose the best source
- For new materials or lots of great value, it is necessary to study carefully to choose the potential source
Purchasing is the initial step in ensuring that a business acquires the right specifications, types, and quality of goods in a timely manner, aligning with customer needs and the company's sales plan.
Figure 3.3: Flow chart Purchasing Materials and Services (Source: SQM procedure
The SCM department oversees the procedure, with SQM participating in step 7, which involves supplier evaluation and specification release if necessary In this step, SQM is tasked with assessing the supplier to ensure compliance with TBV requirements.
If the chosen supplier is either non-existent or blocked in the ASL, a supplier evaluation is necessary Before initiating a Purchase Requisition (PR), the requester, along with the purchasing team and Supplier Quality Management (SQM), will assess the situation.
✓ Will the material be frequently purchased?
✓ Will it be used in the cleanroom?
✓ Will it come into contact with the product in the cleanroom?
✓ Does it need to be released with a part number and specification?
If the answer is affirmative, a part number and specification must be issued Purchasing will inform the suppliers involved in the specification process The material will be procured through a Direct Purchase Order (PO), but the requester is still required to complete the Purchase Requisition (PR) with the released part number.
The TBV conducts Supplier Evaluation (s) to verify the manufacturer's ability to meet the contract's requirements in terms of quality, quantity, delivery method and stable quality control system
The SQM is responsible for developing the supplier audit schedule and execution Supplier is responsible for implementing the required corrective actions from the audit findings
Figure 3.4: Flow chart Audit Supplier Procedure (Source: SQM procedure
✓ Step 1: Start procedure, on-site audits may be performed for additional reasons such as:
When engaging with suppliers, it is essential to conduct a thorough re-evaluation, especially for those with performance concerns or when a for-cause audit is necessary Significant changes, such as new ownership, location shifts, or major equipment and tooling purchases, can impact supplier relationships Additionally, establishing new business with an existing supplier requires careful consideration of these factors to ensure optimal performance and reliability.
42 members of the CFT, capacity/technology changes, convenient timing associated with another trip
✓ Step 2: The Yearly Audit Planning
An annual audit plan will be created by the SQM team for each fiscal year, spanning from April 1 to March 31 This plan may incorporate insights from the CFT's review as necessary It will focus on Level 1 and Level 2 suppliers scheduled for reassessment during the fiscal year, while also considering suppliers not due for reassessment but warranting an audit for various reasons.
When an on-site audit is impractical, infeasible, or unnecessary, proper justification must be documented and added to the Supplier's file This justification should explain how the overall risk profile remains unaffected by forgoing the on-site audit, allowing for the application of an off-site audit instead.
The audit plan will be documented in a memo approved by the SQM and will be updated throughout the fiscal year as needed
A report will be generated at the end of the fiscal year to summarize audit performance to plan
✓ Step 3: Confirm schedule audit with supplier:
SQA will notify the supplier of the audit date and seek alignment on the "Yearly Audit Plan." Additionally, audits may be conducted for reasons such as re-evaluation, performance concerns, or any changes that require verification by Terumo BCT Viet Nam It is essential for SQA to provide the supplier with a two-week notice prior to the audit.
✓ Step 4: Get approval “Yearly audit planing”
After confirmed with supplier about “Yearly audit plan”, Terumo BCT Viet Nam will approve onto offical form planning
✓ Step 5: Monthly tracking the plan
Assessment Application Suppliers Quality Management Procedure At TBV
Supplier data management was efficiently executed using SAP, enabling the SQM team to conserve resources and quickly access information This is particularly beneficial as the data requirements for each supplier vary based on their type and associated risk level.
TBV enhances its supplier management process by categorizing suppliers based on risk levels High-risk suppliers are those that directly provide raw materials, equipment, or tools critical to production and finished products Conversely, suppliers deemed lower risk have a reduced impact on the production process.
Figure 3.23: Suppliers by Risk Level
- Level 1: Product or services have a high direct impact on product quality or safety, regulatory compliance, or business continuity Such as raw material (PVC compound, plasma bag, trays, cassette…)
- Level 2: Product or services have a moderate or indirect impact on product quality or safety, regulatory compliance, or business continuity Such as calibration service, ETO gas, clean room equipment, …
- Level 3: Product or services have a low risk of impact on product quality or safety, regulatory compliance, or business continuity Such as, pest controlling mesh, carton, spare part for production, …
- Level 4: Product or services does not impact product quality or safety, regulatory compliance, or business continuity Such as training ISO performance service, water service, desk, table, transportation service …
❖ About planning for new suppliers
Careful and formal discussions and planning for new suppliers are conducted through meetings involving members of the Cross-Functional Team (CFT) from various departments, including Supplier Quality Management (SQM), Supply Chain Management (SCM), finance, and Subject Matter Experts (SME) This collaborative approach ensures effective planning and alignment between business and manufacturing activities.
- All members of the SQM team can perform supplier quality audits and monitoring thanks to detailed process guidance with tightly defined audit times
- The SQM team audit about suppliers’ quality and the SCM team audit about suppliers’ shipping, that makes the specialization in both aspects of the supplier
- The SQM team reduces wasted time in defining the actions to be addressed
SQA members made a great effort to set a plan and the procedure convenience with both supplier and auditor from TBV
The SQM team occasionally faces challenges when they forget to record and scan supplier documents, resulting in numerous non-conformities (NC) during internal audits by TBV or BSI.
- Documentation of the supplier is not still updated on the SAP This mistake makes SQM members feel struggle when finding some need information, even getting the wrong information
- Some suppliers TBV did not has a plan to business still exist in the approved supplier list
SQA staff often encounter issues when registering document numbers, such as duplicating numbers across different suppliers or assigning numbers without any corresponding supplier These errors lead to wasted time as SQA must rectify the mistakes, provide explanations, and await approval from leadership.
- Because the process is built to comply with the requirements of the FDA and ISO
Documenting tasks as per ISO 13485 is essential for third-party assessments of TBV, but it can overwhelm employees with extensive record-keeping requirements The process of gathering, scanning, and storing necessary documents is time-consuming Typically, SQM members delay documenting and archiving scanned files until a substantial volume is accumulated, leading to stagnant records This results in a lack of accessible scanned documents for other teams, increasing the risk of errors and the misplacement of original paper records.
❖ About data deviation between SAP system and manual file
During the data update in SAP, SQA encountered several issues, including discrepancies between the error re-evaluation date and the data in both the SAP system and the SQA master list file These incorrect re-evaluation dates can result in errors in supplier audit planning, potentially leading to missed audits and acceptance by other auditors.
Due to the shared supplier relationship between Terumo Vietnam and Terumo BCT USA, which primarily sources from the head office in Lakewood, the ability to implement corrective actions for suppliers is restricted This challenge is compounded by the difficulty in persuading suppliers to address issues with the TBV material, which are not present at the Lakewood facility.
It takes a long time for suppliers to respond to defects found in materials If the SQM team blocks these suppliers, production and delivery planning will be seriously affected
Blocked suppliers remain listed in both the ASL file and the SAP system, leading to significant time loss in planning and organizing meetings as the re-evaluation date nears.
Supplier corrective actions by SQA are focused on resolving material issues at the TBV plant through time-consuming sorting processes that require significant human resources However, it is essential to address these problems at the supplier's factory to eliminate their root causes effectively.
Improper positioning of materials in the warehouse can lead to discrepancies with SAP information, complicating material management During the Quarterly Cycle-count, challenges arise when actual stock cannot be located due to misalignment with the BIN register in SAP, hindering the verification of stock accuracy.
In addition, the small Quarantine storage area, and the number of unavailable forklifts
(forklift in the WH department) are also limitations in the procedure